Research, Development and Innovation (R&D&I) in Health of the Rapha Device: Translational Process for the Treatment of Diabetes-Related Foot Disease
Keywords:
Biomedical Engineering, Meshless. Microfluidic devices. Smoothed Dissipative Particle Dynamics., animals exAbstract
Diabetes-related foot disease is one of the most severe complications of diabetes mellitus, potentially leading to ulcers, infections, and, in severe cases, amputation. This article presents the research, development, and innovation (R&D&I) process of the RAPHA device, a technological solution aimed at treating this condition. The study follows a translational approach, seeking the effective clinical application of the device. The methodology involved a literature review, technological development, laboratory testing, and preliminary clinical trials.
The results demonstrate a significant improvement in wound healing and in patients’ quality of life, positioning RAPHA as a promising alternative for treating diabetes-related foot disease. Currently, the device is undergoing technology transfer to the company Life Care, which is responsible for the regulatory steps required for ANVISA registration and INMETRO certification. This process includes multiple stages of regulatory validation and adaptation for large-scale production, ensuring the safety and efficacy of the device for commercialization and distribution within the healthcare market.
The development of RAPHA exemplifies the importance of the university–industry–government triad in fostering technological innovation in healthcare. Collaboration among academic institutions, the productive sector, and regulatory bodies was essential to enable the research, secure necessary funding, and ensure compliance with regulatory standards. This cooperative model strengthens the innovation ecosystem, facilitating knowledge transfer and expanding the social and economic impact of the project.
Downloads
References
ARMSTRONG, D. G. et al. Diabetic Foot Ulcers. JAMA, v. 330, n. 1, p. 62, 2023. Disponível em: https://doi.org/10.1001/jama.2023.10578. Acesso em: 24 abr. 2025.
EDMONDS, M.; MANU, C.; VAS, P. The current burden of diabetic foot disease. Journal of Clinical Orthopaedics and Trauma, v. 17, p. 88–93, 2021. Disponível em: https://doi.org/10.1016/j.jcot.2021.01.017. Acesso em: 24 abr. 2025.
FLEURY ROSA, S. D. S. R. et al. A tecnologia RAPHA e sua incorporação no Sistema Único de Saúde - SUS: inovação de baixo custo dentro dos serviços de saúde. Hegemonia: Revista de Ciências Sociais, v. 24, p. 27, 2018. Disponível em: https://doi.org/10.47695/hegemonia.vi24.244. Acesso em: 24 abr. 2025.
LUO, Y. et al. The incidence of lower extremity amputation and its associated risk factors in patients with diabetic foot ulcers: A meta‐analysis. International Wound Journal, v. 21, n. 7, 2024. Disponível em: https://doi.org/10.1111/iwj.14931. Acesso em: 24 abr. 2025.
MACDONALD, K. E. et al. The microbiology of diabetic foot infections: a meta-analysis. BMC Infectious Diseases, v. 21, n. 1, p. 770, 2021. Disponível em: https://doi.org/10.1186/s12879-021-06516-7. Acesso em: 24 abr. 2025.
MCDERMOTT, K. et al. Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers. Diabetes Care, v. 46, n. 1, p. 209–221, 2023. Disponível em: https://doi.org/10.2337/dci22-0043. Acesso em: 24 abr. 2025.
ROSA, M. F. F. et al. Desenvolvimento de tecnologia dura para tratamento do pé diabético: um estudo de caso na perspectiva da saúde coletiva. Saúde Em Debate, v. 43, spe2, p. 87–100, 2019. Disponível em: https://doi.org/10.1590/0103-11042019s207. Acesso em: 24 abr. 2025.
ZHANG, X. et al. RETRACTED: Risk factors for amputation in diabetic foot ulcers: A retrospective analysis. International Wound Journal, v. 21, n. 4, 2024. Disponível em: https://doi.org/10.1111/iwj.14832. Acesso em: 24 abr. 2025.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2025 Revista Interdisciplinar de Pesquisa em Engenharia
This work is licensed under a Creative Commons Attribution-NoDerivatives 4.0 International License.
Given the public access policy of the journal, the use of the published texts is free, with the obligation of recognizing the original authorship and the first publication in this journal. The authors of the published contributions are entirely and exclusively responsible for their contents.
1. The authors authorize the publication of the article in this journal.
2. The authors guarantee that the contribution is original, and take full responsibility for its content in case of impugnation by third parties.
3. The authors guarantee that the contribution is not under evaluation in another journal.
4. The authors keep the copyright and convey to the journal the right of first publication, the work being licensed under a Creative Commons Attribution License-BY.
5. The authors are allowed and stimulated to publicize and distribute their work on-line after the publication in the journal.
6. The authors of the approved works authorize the journal to distribute their content, after publication, for reproduction in content indexes, virtual libraries and similars.
7. The editors reserve the right to make adjustments to the text and to adequate the article to the editorial rules of the journal.
